Source document or public record
FDA 510(k) K214002 — CRYOcheck Chromogenic Factor IX
FDA 510(k) index record K214002. Device: CRYOcheck Chromogenic Factor IX. Applicant as listed: Precision Biologic, Inc.. Decision date: 2022-12-23.
Source
"device_name": "CRYOcheck Chromogenic Factor IX"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K214002.
Device name: CRYOcheck Chromogenic Factor IX. Applicant as listed: Precision Biologic, Inc..
Decision date: 2022-12-23. Decision wording: Substantially Equivalent.
Product code: GGP. Regulation: 21 CFR 864.7290. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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